Review decisions
Showing 950 results of 2627 total
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS01032
Product Type: Drug
Control Number: 238994
DIN(s): 02516764
Manufacturer: Recordati Rare Diseases Canada Inc.
Submission Type: New Drug Submission
Date Filed / Submission Date: 2020-05-05
Decision / Authorization Date: 2021-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00269
Issued / Original Publication Date: 2021-06-08
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00821
Product Type: Drug
Control Number: 248711
Manufacturer: Pendopharm, Division of Pharmascience Inc.
Submission Type: Application filed under section 3 of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19
Date Filed / Submission Date: 2021-01-25
Decision / Authorization Date: 2021-06-07
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00619
Product Type: Drug
Control Number: 253502
DIN(s): 02527707
Manufacturer: Amylyx Pharmaceuticals Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-06-07
Issued / Original Publication Date: 2022-12-23
Decision / Authorization Date: 2022-06-10
Updated Date: 2025-02-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00824
Product Type: Drug
Control Number: 246922
DIN(s): 02456869
Manufacturer: Merck Canada Inc.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-12-04
Decision / Authorization Date: 2021-06-04
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00818
Product Type: Drug
Control Number: 243600
Manufacturer: Bristol-Myers Squibb Canada Co.
Submission Type: Supplement to a New Drug Submission
Date Filed / Submission Date: 2020-09-03
Decision / Authorization Date: 2021-05-28
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00608
Product Type: Drug
Control Number: 253182
DIN(s): 02527677
Manufacturer: FORUS Therapeutics Inc.
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2022-10-12
Decision / Authorization Date: 2022-05-31
Updated Date: 2023-07-17
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1731596920959
Product Type: Drug
Control Number: 252929
Manufacturer: Celltrion Healthcare Co. Ltd.
Submission Type: New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Date Filed / Submission Date: 2021-05-28
Decision / Authorization Date: 2024-07-31
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684957849549
Product Type: Drug
Control Number: 253186
DIN(s): 02533979, 02533987, 02533995
Manufacturer: AbbVie Corporation
Submission Type: New Drug Submission (New Active Substance)
Date Filed / Submission Date: 2021-05-28
Issued / Original Publication Date: 2023-04-20
Decision / Authorization Date: 2022-12-22
Updated Date: 2026-01-06
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00268
Issued / Original Publication Date: 2021-05-27